Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Ivenix Infusion System is a large volume pump used in hospitals and other health care settings to give fluids to patients in precisely controlled infusion amounts and rates. The system delivers blood or blood products, drugs, and other fluid mixtures through blood vessels, the back/spine (epidural), or beneath the skin (subcutaneous). It is used for adults and pediatric patients I.e.neonates, infants, children and adolescents.

Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System due to a leak in the system that allows fluid to enter the Administration Set Loading Area near the Air Detector. The leak damages the electrical system, leading to loss of power and failure of the system’s Set Identification (Set ID) sensor. Depending on the timing of the failure, this can delay or interrupt treatments.

This issue may cause serious injury or death to patients due to interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications. Fresenius Kabi USA has received 14 complaints related to this issue. There have been no reported injuries or deaths.

On March 10, 2023, Fresenius Kabi USA sent an Urgent Medical Device Recall letter to customers with the following recommendations for users and customers:

Ensure an additional and functioning large volume pump is available in treatment situations where infusion interruption could be dangerous, such as when the system is delivering life-sustaining medications, fluids, and blood products.

Use a different large volume pump if unable to start or resume an infusion based on provided instructions.

Take notice of functioning alarms and alerts.

Avoid fluid buildup at the Air Detector and wipe any liquid off the Air Detector areas after cleaning and disinfection, or if a spill occurs on the pump, per the Instructions For Use (IFU).

Inspect the Air Detector to ensure there is not fluid present or visible fluid spots on the surface of the Air Detector if the pump shows:

“Reload Cassette” alert during set up.

“Tubing Set Removed” audible and visual alarm during use.

Report persistent “Reload Cassette” alerts and any failures of the pump to recognize the administration set after re-insertion to biomedical engineers and use another pump.

Remove Ivenix Infusion Systems from use and contact Fresenius Kabi if “Reload Cassette” alerts or “Tubing Set Removed” alarms continue after biomedical engineers inspect and re-clean the Air Detector area of the system.

Consider posting these recommended steps at each nursing station.

Customers were requested to complete and return an enclosed response form. The company plans to contact them to schedule repair of affected systems and replacement if repair is not possible.

Customers with questions about this recall may contact Fresenius Kabi USA at [email protected] or 1-978-775-8100.

Medical Device Recall Database Entry

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

04/19/2023